Company* (Country; Symbol)

Product

Description

Indication

Status (Date)


AUTOIMMUNE

Biogen Idec Inc. (BIIB) and Elan Corp. plc (Ireland)

Antegren (natalizumab)

Humanized monoclonal antibody; alpha-4 antagonist in the selective adhesion molecule inhibitor class

Multiple sclerosis

Filed BLA with the FDA following decision in February to file on one- ear data on 2,100 patients instead of two-year data; the trial will continue, so results were not disclosed (5/25)

CANCER

Allos Therapeutics Inc. (ALLP)

RSR13 (efaproxiral)

Small molecule designed to sensitize hypoxic areas of tumors prior to radiation

Brain metastases

FDA advisory panel recommended against approving the product for treating patients with metastases originating from breast cancer (5/3)

American BioSciences Inc.*

Abraxane

Nanoparticle albuminbound taxane

Metastatic breast cancer

The FDA accepted for filing the NDA on Abraxane, which was submitted in March (5/10)

Cell Genesys Inc. (CEGE)

GVAX

Whole-cell vaccine comprised of tumor cells irradiated and modified to secrete GM-CSF

Prostate cancer

Received a special protocol assessment from the FDA for upcoming Phase III trial in hormone-refractory, metastatic disease (5/10)

Favrille Inc.*

FavId

Vaccine designed to stimulate immune responses

Non-Hodgkin's lymphoma

Got FDA special protocol assessment for upcoming Phase III trial to use product after Rituxan treatment in patients with follicular B-cell NHL; trial is expected to start in3Q:04 (5/19)

Genta Inc. (GNTA) andAventis SA (France)

Genasense

Oblimersen sodium; inhibits function of bcl-2 protein

Advanced melanoma

FDA advisory panel said drug and dacarbazine failed to demonstrate effectiveness vs. dacarbazine alone (5/3); companies terminated expanded access program for the drug (5/28)

Inex Pharmaceuticals Corp. (Canada; TSE:IEX) and Enzon Pharmaceuticals Inc. (ENZN)

Onco TCS

Vincristine encapsulated in Inex's TCS (liposomal) drug delivery technology

Relapsed, aggressive non- Hodgkin's lymphoma

The FDA accepted the NDA for the product and designated it for standard review (5/21)

Pharmion Corp. (PHRM)

Vidaza

Azacitidine for injectable suspension; believed to have demethylation and cytotoxic actions

Myelodysplastic syndromes

The FDA approved the drug for all five MDS subtypes; the drug has orphan status in the U.S. (5/19)

Progen Industries Ltd. (Australia; ASX:PGL)

Pi-88

Anti-angiogenesis drug also is designed to inhibit tumor-promoting factors

Malignant melanoma

FDA granted orphan designation to the product in that indication (5/3)

Therion Biologics Corp.*

Panvac-VF

Vaccine designed to stimulate the immune system to target and destroy cells expressing CEA and mucin-1

Metastatic pancreatic cancer

Reached agreement with FDA under special protocol assessment for pivotal Phase III trial in 250 patients who have failed gemcitabine treatment (5/24)

Xenova Group plc (UK; XNVA)

TransMID

Modified diphtheria toxin conjugated to transferrin

Glioblastoma multiforme

Reached agreement with FDA under special protocol assessment to run two smaller Phase III trials rather than one large study; the first trial will have 323 patients (5/11)

CARDIOVASCULAR

Dyax Corp. (DYAX)

DX-88

Recombinant small protein designed to inhibit human plasma kallikrein

Hereditary angioedema

The FDA put a hold on the clinical program, which is in Phase II, until resolution of questions regarding preclinical animal studies (5/25)

Inotek Pharmaceuticals Corp.*

INO-1001

Inhibitor of the nuclear cell death enzyme (ADP-ribose) polymerase

Thoraco- abdominal aortic aneurysm

The FDA designated it a fast- track product for complications associated with TAAA repair surgery; the drug is nearing Phase II (5/24)

CENTRAL NERVOUS SYSTEM

Endo Pharmaceuticals Inc. (ENDP) and SkyePharma plc (UK; SKYE)

DepoDur (previously named DepoMorphine)

Sustained-release, injectable liposomal formulation of morphine

Post-surgical pain

The FDA approved the product for treating pain following major surgery; launch is expected by the end of the year (5/19)

Endo Pharmaceuticals Inc. (ENDP)

Oxymorphone

Entended-release formulation of oxymorphone

Pain

Company will initiate a new trial to provide additional data; decision followed meeting with FDA, which issued approvable letter in October 2003 calling for more study (5/6)

Phase 2 Discovery Inc.*

PD-6735

Melatonin analogue; agonist at melatonin-1 and melatonin-2 receptors

Circadian sleep disorders

The FDA granted orphan designation to the product in treating the disorders in blind individuals (5/26)

INFECTION

Gilead Sciences Inc. (GILD)

Viread and Emtriva (both FDA-approved)

Nucleotide and nucleoside reverse transcriptase inhibitors, respectively

HIV

The FDA granted priority review to NDA on the fixed-dose co-formulation of the drugs; the NDA was filed in March (5/17)

Octapharma AG* (Switzerland)

Octagam

Liquid solvent/detergent- treated immunoglobulin intravenous (IGIV) product

Primary immunodeficiency diseases

The FDA granted the product approval in that indication; it has been available in Europe for 10 years (5/24)

Sinovac Biotech Inc.* (China; OTC BB:SNVBF)

--

Vaccine for severe acute respiratory syndrome

SARS

Began trial in healthy volunteers in Beijing; said no abnormal reactions resulted from first four inoculations (5/23)

Vicuron Pharmaceuticals Inc. (MICU)

Anidulafungin

Broad-spectrum agent from the echinocandin class

Esophageal candidiasis

FDA issued approvable letter stating NDA does not support approval; agency said approval could be possible after completion of ongoing Phase III trial (5/24)

MISCELLANEOUS

Adolor Corp. (ADLR) and GlaxoSmithKline plc (UK)

Entereg (alvimopan)

Mu opioid antagonist

Post-operative ileus

Adolor submitted the first portion of its NDA for Entereg, which has fast-track status (5/7)

Indevus Pharmaceuticals Inc. (IDEV)

Sanctura (trospium chloride)

Quarternary ammonium anticholinergic compound; muscarinic receptor antagonist

Overactive bladder

The FDA approved the product, which already is sold in Europe and will be co- promoted by Pliva d.d. (5/28)

Isolagen Inc.
(AMEX:ILE)

Isolagen Process

Autologous cellular therapy

Nasolabial folds and glabellar lines

Reached agreement with the FDA on special protocol assessment covering two pivotal Phase IIIstudies (5/23)

ISTA Pharmaceuticals Inc. (ISTA)

Xibrom

Bromfenac sodium solution; topical non-steroidal anti-inflammatory agent

Ocular inflammation following cataract surgery

Filed NDA with the FDA seeking approval in that indication (5/25)

ISTA Pharmaceuticals Inc. (ISTA)

Vitrase

Ovine hyaluronidase formulation

Spreading agent

The FDA approved the agent for use as a spreading agent to facilitate the dispersion and absorption of other drugs (5/6)


Notes:

* Privately held

Unless otherwise noted, the stock symbols listed for public companies are on the Nasdaq market.

AMEX = American Stock Exchange; ASX = Australian Stock Exchange.

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